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A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology

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ClinicalTrials.gov Identifier: NCT04505956
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Nicole L. Miller, Vanderbilt University Medical Center

Brief Summary:
Flexible ureteroscopy is characterized as first-line therapy for the treatment of renal stones < 2 cm in size. This involves passing a flexible endoscope into the renal pelvis through the urethra, bladder and ureter in a retrograde fashion. Holmium: YAG laser remains the preferred energy modality to subsequently break stones of this size into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the "Moses Effect" - the creation of vapor bubbles/cavities between the laser fiber tip and the target through which laser energy can more efficiently travel. Lumenis was the first to optimize this laser phenomenon and market it as "Moses Technology" in their Lumenis Pulse P120H laser system. This system is already FDA approved through the 510K pathway and is commercially available. The purpose of this study is to evaluate the potential of Moses laser technology to reduce operative time compared to non-Moses settings for ureteroscopic treatment of nephrolithiasis.

Condition or disease Intervention/treatment Phase
Nephrolithiasis Device: Holmium laser lithotripsy with Moses Technology Device: Holmium laser lithotripsy without Moses Technology Not Applicable

Detailed Description:

There is ongoing debate on the optimal means of laser stone fragmentation, and Moses technology is the latest advancement to raise questions regarding clinical utility. Initial preclinical studies demonstrated significantly reduced stone retropulsion and higher stone ablation volume with Moses technology, leading to the conclusion that the system allows more efficient laser lithotripsy. Human studies also showed that laser lithotripsy with Moses technology utilized laser energy in less time for stone fragmentation: 10.0 (2.6-15.0) min without vs 6.0 (2.8-13.0) min with Moses technology.

Others have evaluated the cost effectiveness of Moses technology in their own cohort of 40 patients who underwent standard laser lithotripsy by comparing a 35% projected decrease in procedure time against the cost of the Moses laser fiber and machine. Mean stone size was 10.2 mm in this group of patients, and mean lasing time was 3.0 minutes. While a significant positive association was seen between stone size and laser time, cost analysis failed to show a benefit in using Moses technology across sizes.

To date, there are limited clinical data obtained through rigorous study methodology. In addition, knowledge gaps remain regarding the effect of Moses technology on other clinically meaningful outcomes such as stone-free rate. Therefore, the investigators propose a multi-center, prospective, randomized, double blind clinical trial to further assess the effect of Moses technology for lithotripsy. The investigators aim to study a broader range of outcomes which will be facilitated by being the largest study to date. The investigators also aim to study novel outcomes such as grading retropulsion and visibility by independent blinded review as well as effects of Moses technology on independently reducing surgeon burnout. Indeed, a randomized, double blind clinical trial evaluating Moses technology in 66 patients undergoing ureteroscopy was presented as a 2018 European Association of Urology abstract. While this single center study demonstrated safety and reduced fragmentation time as well as procedure time using Moses technology, it did not show a significant difference in stone-free rates. This study is also yet to be published as a manuscript.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double Blind Clinical Trial to Compare Holmium Laser Lithotripsy With and Without Moses Laser Technology for the Ureteroscopic Treatment of Nephrolithiasis
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones
Drug Information available for: Holmium

Arm Intervention/treatment
Experimental: Moses Laser Lithotripsy
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.
Device: Holmium laser lithotripsy with Moses Technology
Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
Other Name: Moses Laser Lithotripsy

Active Comparator: Standard Laser Lithotripsy
Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.
Device: Holmium laser lithotripsy without Moses Technology
Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
Other Name: Standard Laser Lithotripsy




Primary Outcome Measures :
  1. Operative Time [ Time Frame: Beginning to end of procedure time ]
    Total operative times between Moses holmium laser lithotripsy and non-Moses holmium laser lithotripsy in the ureteroscopic treatment of renal stones using a dusting technique


Secondary Outcome Measures :
  1. Stone retropulsion [ Time Frame: First 20 seconds of laser lithotripsy ]
    Stone movement during laser lithotripsy will be recorded on video and graded on a Likert scale by blinded reviewers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Solitary renal stone 8 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 8-20 mm is required
  • Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
  • Must be 18 years or older
  • Must be able to give consent

Exclusion Criteria:

  • Concomitant stones in the ureter
  • Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
  • Prior radiotherapy to the abdomen or pelvis
  • Neurogenic bladder or spinal cord injury
  • Pregnancy
  • Untreated UTI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505956


Contacts
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Contact: Naren Nimmagadda, MD (615) 343-1317 naren.nimmagadda@vumc.org

Locations
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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Seth Bechis, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Ojas Shah, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Lipkin, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sriharan Sivalingam, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Nicole Miller, MD         
Contact: Naren Nimmagadda, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Study Director: Naren Nimmagadda, MD Vanderbilt University Medical Center
Publications:

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Responsible Party: Nicole L. Miller, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04505956    
Other Study ID Numbers: Moses Ureteroscopy RCT
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nicole L. Miller, Vanderbilt University Medical Center:
Ureteroscopy
Nephrolithiasis
Kidney Stone
Lithotripsy
Holmium
Moses
Additional relevant MeSH terms:
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Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical